Job Description – Quality Officer
Contract Role: 12 months
Reporting to: Quality Manager
This position will ensure that excellent standards of quality are maintained throughout the business processes at Kora Healthcare and the standards are continuously monitored and improved. The key areas of responsibility lie within the areas of SOP preparation and control, Packaging, Vendor Management, Internal Auditing & Quality Control. The position will be reporting into the Quality Manager but will work closely with other roles within the Quality Department and Regulatory Affairs/Pharmacovigilance, Research & Development and Supply Chain Departments.
Key Duties & Responsibilities
- Working with Packaging Designers and Suppliers, generating new/revised product packaging and labelling artwork
- Maintaining and updating packaging specifications in both in soft copy and hardcopy
- Maintaining and updating Quality Documents associated with product packaging
- Preparation and updating of company SOPs relevant to product packaging and labelling
- Coordinating the review and approval of packaging artwork and labelling in line with Standard Operating Procedures
- Carry-out and co-ordinate assigned internal audits and ensure the review, monitoring, reporting of the inspections. Ensure audit action items are closed within agreed timeframe.
- Assist with audits and checks on suppliers and ensure the review, monitoring and reporting of the audits.
- Assist with preparation for Health Authority and Notified Body inspections and prepare regulatory inspection responses.
- Assist with facilitating inspections of the company by Third Parties.
- Monitoring and reporting Key Performance Indicators associated with Vendors/Suppliers
- Assist with the preparation and regular review of Technical Agreements with all relevant suppliers.
- Maintaining and updating Quality Documents associated with Vendors
- Maintain Vendor management system ensuring all necessary quality documentation associated with each vendor is updated as required and properly filed.
- Update and review SOPs as required via eQMS.
- Ensure updated SOPs are reviewed and signed by all relevant departments.
- Ensure the correct revision of SOPs is in circulation at all times.
- Manage superseded and obsolete SOPs correctly.
- Controlling and maintaining the document archive and sample retention system.
- Provide administrative and/or technical support with respect to preparation, assembly, filing and distribution of information relating to product registrations, compliance and pharmacovigilance.
- Assist with the maintenance the product technical documents.
- Assist with the preparation of the Quality Management Reviews and Product Quality Review.
- Ensure that training plans are implemented and training records are maintained.
- Generation and reporting of relevant Quality metrics.
- Perform other tasks as will be required from time to time.
- 3rd level qualification in a science discipline.
- 3 year minimum experience in the medical devices and / or pharmaceutical industries. Specific experience working in a quality environment is a requirement for this position.
- Strong background in the application of ISO 13485 and GMP/GDP standards.
- Previous experience in regulatory inspections, supplier audits and customer audits.
- Strong organisational skills, ability to prioritise work and systematic approach to tasks.
- Highly motivated self-driven and “can-do-attitude”.
- Enjoy and thrive in a fast paced environment.
- Kora Healthcare works with stakeholders within and outside the company, the ideal candidate will demonstrate excellent interpersonal, communication and presentation skills, strong analytical and problem solving skills.
- Applicants must also possess the ability to work well both on their own initiative and also within a team environment.
- High level of proficiency in Microsoft Word and Excel.
- Proficiency in speaking, comprehending, reading and writing English is required.
Kora Healthcare Values:
- Urgency, Drive and personal accountability
- Value our customers
- Respect for our employees
To apply for this position: please email cover letter and CV to KoraCareers@korahealthcare.com quoting job title in the subject line